BEUDAMED
    FDA Enforcement Class II Terminated

    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.

    Recall: Z-1530-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1530-2014
    Event ID
    67897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alfa Wassermann, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    April 29, 2014
    Termination Date
    August 13, 2015
    Address
    4 Henderson Dr, West Caldwell, NJ, 07006-6608, United States

    Description

    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.

    Reason

    Extremely low absorbance readings.

    Code Info

    ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)

    Distribution

    US Nationwide Distribution

    Quantity

    SA1047 lot F3609: 146; RX1047 lot F3610: 53